The present invention relates to devices for injecting liquid into a body cavity to effect cleaning thereof and, more particularly, a device for irrigation of an external ear canal with lavage fluid.
Various irrigation devices are known for cleaning human body cavities. For example, such devices are used routinely for cleaning the ears of a patient. Most commonly, a flexible bulb is fitted to a nozzle through which the lavage fluid is discharged into the ear canal of a patient.
Bulb-type devices have several drawbacks. First, the bulb capacity limits the usage of the device since the bulb contains a relatively small quantity of the lavage fluid and, to fully irrigate a patient's ear, the bulb has to be refilled a number of times.
Second, the pressure of the lavage fluid exiting the nozzle and impinging upon the ear canal can not be readily controlled in a reliable manner. This lack of control produces inconsistent results and can in turn, cause pain and injure a patient due to the sensitivity of the tympanic membrane.
Third, an inconvenience related to collection of the waste fluid discharged from the cavity. In the majority of prior art devices a basin is used to collect the waste fluid. If the basin is not used, then the patient must be irrigated in the vicinity of a sink in order to avoid spillages and further usually require the use of towels, drapes, and other accessories to attend to the discharged lavage fluid. Using either method, the collection of waste fluid from a cleaning procedure is tedious and messy, as well as inefficient.
There is known an ear irrigator which delivers a stream of water into an ear canal, body cavity or wound in small volume bursts of short duration. The device comprises a bottle containing a volume of water and attached to a hand-held pump actuated by squeezing the trigger, a flexible tube with a splash shield connected to the outlet of the pump, and an end tube connected to the free end of the main conduit tube, the end tube being of reduced outer and inner diameter relative to the flexible tube. The transition from a relatively large internal bore in the flexible tube to a small internal bore in the end tube creates a high velocity flow at the tip and causes the end tube to oscillate during the delivery of the water stream that creates a pulsing water stream relative to any particular location in the ear canal and may be more effective in removing ear wax and debris than a steady stream of water. Although the device is an improvement in terms of the liquid capacity, it does not address the other inadequacies of the bulb-type devices.
Another known irrigation devices include a pump, connected to a fluid reservoir, and driven by an electric motor. Such devices are capable of pulsatingly or continuously ejecting water from a nozzle opening for a sustained period of time, but do not generally include temperature and pressure indicators for monitoring the temperature and pressure of the water issuing from the nozzle. The use of an electric motor also has a number of inherent disadvantages, including a necessarily maintenance of the device and the noise of the motor, which can be annoying and stressful both for the operator and the person whose ear is being cleaned.
Fountain-type irrigation devices which are adapted to be connected with a pressure water supply such as at a faucet, on top of having some of the disadvantages of the pump devices, are generally suited for cleaning ears with water only, feature long tubes that necessitate prolonged flashing for stabilizing of the water temperature and inconvenient for the operator, and require pressure relief valves with a separate drain line for dampening of water supply pressure fluctuations. Moreover, the rapid opening and closing of the relief valve can itself create a pulsating flow from the nozzle opening.
A common problem of using the irrigation devices with continuous supply of the lavage fluid is the waste fluid evacuation. Due to the continuous flow, a protection of patient clothes and the collection of waste fluid from a cleaning procedure are more challenging than with the manual devices. Known in the fountain-type irrigation devices, a vacuum assisted evacuation can work effectively only under certain conditions, which are not sustainable in real settings.
Another problem long encountered in the field pertains to the temperature of lavage fluid being discharged into the body cavity, especially in those systems that utilize a continuous lavage fluid supply. Lavage fluid which is too hot can create discomfort and in other cases could seriously injure the patient. It has further been determined that lavage fluid which is too cold will not allow optimal cerumen removal. It has been determined that optimal removal is achieved using lavage fluid which is at approximately body temperature.
Each of the known devices is intended to remove cerumen which has accumulated in the external ear canal. However, each of the known devices involves the possibility of damaging the tympanic membrane, the necessity of professional care, or both. However, with each visit to a doctor, costs are incurred. As well, the time spent by patients in attending at doctors' offices to have cerumen removed is cumulatively significant.
Therefore it would be desirable to provide an inexpensive, ready and easy to use a body cavity irrigation device capable of holding sufficient volume of lavage fluid, discharging the lavage fluid at a safe and effective pressure, and evacuating reliably waste fluid directly from the cavity. Additionally, it would be desirable if such device included a temperature indicator, which could be used for adjusting and monitoring the temperature of the lavage fluid at the time of use. Further, such device should preferably be safe and convenient for users to self administer the cavity irrigation with no professional supervision.